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FDA 510(k)

Straumann PURE Ceramic Implants

K-Number: K171769 · 2017-11-14

ApplicantStraumann USA, LLC (On Behalf of Institut Straumann Ag)
Decision Date2017-11-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann PURE Ceramic Implants is a medical device manufactured by Straumann USA, LLC (On Behalf of Institut Straumann Ag). It received FDA 510(k) clearance on 2017-11-14 under approval number K171769. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Straumann PURE Ceramic Implants?

Straumann PURE Ceramic Implants is a medical device that received FDA 510(k) clearance on 2017-11-14. It is manufactured by Straumann USA, LLC (On Behalf of Institut Straumann Ag). The 510(k) number is K171769.

When was Straumann PURE Ceramic Implants approved by the FDA?

Straumann PURE Ceramic Implants received FDA 510(k) clearance on 2017-11-14, under approval number K171769.

What company makes Straumann PURE Ceramic Implants?

Straumann PURE Ceramic Implants is manufactured by Straumann USA, LLC (On Behalf of Institut Straumann Ag).

What is the FDA product code for Straumann PURE Ceramic Implants?

The FDA product code for Straumann PURE Ceramic Implants is DZE.

Related Clinical Trials

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Other Devices by Straumann USA, LLC (On Behalf of Institut Straumann Ag)

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Related Devices (Code: DZE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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